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Immunomodulatory Agent
Selinexor + Lenalidomide for Multiple Myeloma
Phase 2
Recruiting
Led By Mark Schroeder, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients ≥18 years of age at time of enrollment
MRD-positive (per 10^-5 threshold) using clonoSEQ MRD® assay on bone marrow biopsy prior to study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months from study treatment initiation
Awards & highlights
Study Summary
This trial tests a combo of 2 drugs to treat multiple myeloma after transplant, to see if it's more effective than just one.
Who is the study for?
Adults diagnosed with multiple myeloma who've had a stem cell transplant and are MRD-positive can join. They must have responded well to prior treatments, be in good physical condition, and have their major organs functioning properly. Pregnant or breastfeeding women, those with uncontrolled infections or heart issues, recent surgery patients, and individuals on other clinical trials cannot participate.Check my eligibility
What is being tested?
This phase II trial is testing the effectiveness of adding Selinexor to Lenalidomide for patients with multiple myeloma post-transplant. The study compares the combination treatment's efficacy against using Lenalidomide alone to see if it improves outcomes.See study design
What are the potential side effects?
Selinexor may cause nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Lenalidomide can also lead to blood clots, rash or itching skin reactions. Dexamethasone might result in mood swings, increased appetite and weight gain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My bone marrow test shows minimal residual disease.
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I have been diagnosed with multiple myeloma and have amyloid deposits in my bone marrow.
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I can take care of myself and perform daily activities.
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I am registered in the Revlimid REMS program and agree to follow its rules.
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I have been treated with a lenalidomide-based regimen.
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I had a stem cell transplant for my multiple myeloma between 80 and 140 days ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months from study treatment initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months from study treatment initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Minimal Residual Disease (MRD) negativity
Secondary outcome measures
Progression-free survival (PFS)
Rate of partial response or better
Trial Design
2Treatment groups
Experimental Treatment
Group I: Maintenance: Selinexor and LenalidomideExperimental Treatment2 Interventions
Maintenance will consist of selinexor and lenalidomide for a maximum of 8 28-day cycles.
Group II: Consolidation: Selinexor, Lenalidomide, and DexamethasoneExperimental Treatment3 Interventions
Consolidation will begin between Days 80 and 140 following standard of care autologous hematopoietic stem cell transplant and the treatment will consist of selinexor, lenalidomide, and dexamethasone for 4 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,660 Total Patients Enrolled
31 Trials studying Multiple Myeloma
2,182 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,544 Total Patients Enrolled
22 Trials studying Multiple Myeloma
2,185 Patients Enrolled for Multiple Myeloma
Mark Schroeder, M.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Multiple Myeloma
48 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an organ transplant and am on immunosuppressive drugs.I am 18 years old or older.I do not have any serious health or mental conditions that could stop me from completing treatment.I have stomach or intestine problems that affect my eating or medication absorption.My blood tests for organ function are within normal ranges.I have not had major surgery in the last 14 days.I do not have active, uncontrolled Hep B, untreated Hep C, or HIV.I do not have severe nerve damage or moderate nerve damage with pain.I have previously taken selinexor or a similar medication.My bone marrow test shows minimal residual disease.I do not have serious heart problems or recent heart attacks.I have been diagnosed with multiple myeloma and have amyloid deposits in my bone marrow.I can take care of myself and perform daily activities.I am registered in the Revlimid REMS program and agree to follow its rules.I am allergic or intolerant to the study medication or similar drugs.I have been treated with a lenalidomide-based regimen.I am scheduled for or have had two stem cell transplants using my own cells.I am not receiving, nor planning to receive, other treatments for my multiple myeloma.I have not needed IV drugs for an infection in the last week.I had a stem cell transplant for my multiple myeloma between 80 and 140 days ago.I have had plasma cell leukemia or myeloma that spread to the brain.You have responded very well to previous treatment according to specific criteria.I am not pregnant or breastfeeding.My condition did not improve with Lenalidomide treatment.I am currently being treated for another cancer.My multiple myeloma has worsened before joining this study.
Research Study Groups:
This trial has the following groups:- Group 1: Consolidation: Selinexor, Lenalidomide, and Dexamethasone
- Group 2: Maintenance: Selinexor and Lenalidomide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this research project for participants?
"According to the clinicaltrials.gov website, this medical study is not taking on any new patients at present. The trial was first available for viewing on June 30th 2023 and it's most recent edit occured April 6th 2023. However, there are 898 other studies actively searching for volunteers right now."
Answered by AI
Has the Administration of Food and Drugs greenlit Consolidation: Selinexor, Lenalidomide, and Dexamethasone?
"Our team at Power gauged the safety of Consolidation: Selinexor, Lenalidomide, and Dexamethasone as a two due to its Phase 2 status. This indicates that there is evidence for its security, albeit with no clinical data confirming efficacy."
Answered by AI
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